The director of the Food and Drug Administration’s vaccine division said in a memo to agency staff on Friday that a review had found that at least 10 children had died “after and because of” getting a Covid vaccination.
Dr. Vinay Prasad, the director, suggested in the memo that the deaths were related to myocarditis, or inflammation of the heart muscle.
The memo, obtained by The New York Times and not publicly released, did not provide details such as the ages of the children, whether they had any other health problems or how the agency determined the vaccine-death link. Nor did it disclose the maker of the vaccines involved.
“This is a profound revelation,” Dr. Prasad wrote in a memo to staff members. “For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children.”
Dr. Prasad declined to be interviewed for this article.
His missive represents another sharp U-turn by federal authorities under Robert F. Kennedy Jr., the nation’s health secretary and a longtime vaccine critic who has frequently described the Covid vaccines as unsafe.
In contrast, health officials in the first Trump administration, when the vaccines were developed during the pandemic, and in the Biden years, strongly endorsed the Covid shots as lifesaving measures.
Mr. Kennedy’s team has issued new policies that are limiting access to the shots to people 65 and older as well as to younger people with underlying medical conditions.
Public health experts have vociferously disputed assertions by Mr. Kennedy and health officials in this Trump administration that the Covid vaccines are dangerous. Previous federal health officials have acknowledged serious but rare side effects from the shots, including the incidence of myocarditis among teenage boys and young men.
But those public health experts have also pointed to the number of lives saved by the shots and to the fact that the virus caused more than a million deaths among Americans. About 2,100 children have died of Covid since the pandemic began, according to the American Academy of Pediatrics.
The findings of the new F.D.A. review have not been published in a peer-reviewed medical journal.
Dr. Paul Offit, a vaccine expert with the Children’s Hospital of Philadelphia and a critic of Mr. Kennedy’s vaccine policies, called the memo an example of science “by press release.”
He said the memo was devoid of context such as the number or rate of deaths from the virus itself among vaccinated and unvaccinated children.
Dr. Offit said children with vaccine-related myocarditis showed up at the hospital, with cases that resolved quickly.
“On the other hand, we saw children admitted to our hospital with myocarditis from the virus,” he said. “It was quite severe and caused admissions to the intensive care unit.”
Some of Mr. Kennedy’s anti-vaccine allies have been pressuring the government for years to delve deeper into the agency’s database that includes unverified reports of harmful effects from the Covid shots. The memo said the analysis of deaths reported to the agency was led by Dr. Tracy Beth Hoeg, a senior F.D.A. adviser and a vaccine skeptic, and reviewed by a team at the agency.
In his memo, Dr. Prasad also announced changes to vaccine oversight and approval, saying there would be a requirement for randomized studies to include all subgroups, such as pregnant women. In addition, he labeled the annual framework for choosing the flu vaccine as a “catastrophe of low-quality evidence,” and said it would also be re-examined.
Dr. Prasad’s memo is landing just before next week’s meeting of the Centers for Disease Control and Prevention’s influential vaccine committee. Mr. Kennedy’s handpicked panel includes supporters of the so-called medical freedom community, who often eschew vaccines and oppose mandates.
Michael Osterholm, a critic of Mr. Kennedy’s health agency oversight and an infectious disease expert at the University of Minnesota, said he believed the memo was intentionally released before the meeting.
“This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events,” he said.
The C.D.C. committee is expected to discuss the broader childhood vaccine schedule.
It also plans to review the hepatitis B vaccine, which Mr. Kennedy and others have targeted as unnecessary for newborns. Proponents of the inoculation say it is the best way to protect against transmission from mother to child.
The C.D.C. panel has also formed a subgroup to specifically review Covid vaccines, under the leadership of Retsef Levi, an M.I.T. management expert who called them a failed product that causes “serious harm including death.”
Dr. Peter Marks, who led the F.D.A. division that regulated vaccines during the pandemic, said he was taken aback by the “clearly political tone of the communication.”
He agreed that the case reports needed to be opened to further scrutiny.
“I would not be surprised if the attributions turn out to be debatable, as these cases are often quite complex,” Dr. Marks said after reading the memo.
Dr. Prasad, whose leadership style has rankled some people internally and outside the agency, complained in the memo of staff members who disagreed with agency’s direction and new policies, saying they were leaking information. He then outlined how employees could submit their resignations. The memo follows a recent missive exhorting staff members to refrain from publishing “obviously erroneous work” instead of work that furthers the agency’s mission.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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